title: Passive-fixation lead failure rates and long-term patient mortality in subjects implanted with Sprint Fidelis electrodes.
abstract: OBJECTIVE
  To evaluate passive-fixation lead failure rates and long-term patient survival in subjects implanted with Sprint Fidelis electrodes.
  
  
  RESULTS
  We identified 748 subjects who received a Sprint Fidelis (n = 429; Medtronic models 6948: 94.8%, 6949: 2.6%, 6930: 1.9%, 6931: 0.7%) or a Sprint 'non-Fidelis' implantable cardioverter defibrillator lead (n = 319, Medtronic models 6944: 68.6%, 6947: 17.9%, 6942: 7.8%, 6943: 3.4%, 6945: 2.2%) at our centre between 1998 and 2008. Kaplan-Meier patient survival was lower in the Fidelis group than in the Control cohort (68.4 vs. 77.0% at 5 years, P = 0.0061), but multivariate analyses revealed no significant association between mortality and implanted lead type. Passive-fixation lead failure rate at 5 years was 14.4% (95% confidence interval (CI) [9.2, 19.3]) in the Fidelis (n = 414) group and 1.8% (95% CI [0.0-3.8]) in the Control (n = 241) cohort (P < 0.001 upon multivariate comparison).
  
  
  CONCLUSIONS
  Failure rates of passive-fixation Sprint Fidelis leads are increased and similar to those previously reported for active-fixation Fidelis electrodes. Despite the elevated risk for lead failure and its potential sequelae, the Sprint Fidelis has no obvious impact on long-term mortality.
authors.affiliation: Division of Clinical Electrophysiology, Department of Cardiology and Pneumology, University Medical Center Göttingen, Georg-August-University, Robert-Koch-Str. 40, 37075 Göttingen, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Vollmann
authors.forename: Sandra
authors.initials: S
authors.lastname: Woronowicz
authors.forename: Lukasz
authors.initials: L
authors.lastname: Kmiec
authors.forename: Klaus
authors.initials: K
authors.lastname: Jung
authors.forename: Dieter
authors.initials: D
authors.lastname: Zenker
authors.forename: Joachim
authors.initials: J
authors.lastname: Seegers
authors.forename: Samuel
authors.initials: S
authors.lastname: Sossalla
authors.forename: Marc
authors.initials: M
authors.lastname: Dorenkamp
authors.forename: Christian
authors.initials: C
authors.lastname: Sohns
authors.forename: Lars
authors.initials: L
authors.lastname: Lüthje
authors.forename: Gerd
authors.initials: G
authors.lastname: Hasenfuss
authors.forename: Markus
authors.initials: M
authors.lastname: Zabel
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects; D004554:Electric Countershock / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality*; D005260:Female; D005858:Germany; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality* / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: ICD; Lead failure; Mortality; Passive fixation